FDA Must Act on Subtherapeutic Antibiotic Use in Farm Animals

For many years medical organizations have warned about the link, now considered definitive, between the subtherapeutic uses of antibiotics in farm animals to stimulate growth and improve feed efficiency, and the crisis of antibiotic resistance in humans. The list of organizations is long and includes the American Medical Association, the American Academy of Pediatrics, Infectious Diseases Society of America, the Center for Disease Control and Prevention (“CDC”), Institute of Medicine of the National Academy of Sciences and the World Health Organization. Indeed, a CDC task force recently reported that “[w]e are facing the possibility of a future without effective antibiotics for some infections.” Hundreds of organizations have recommended that livestock producers be prohibited from using antibiotics for growth promotion if those antibiotics are also used in human medicine.

Even the agency with the authority over the drugs, the Food and Drug Administration (“FDA”), has, for over thirty-five years, “taken the position that the widespread use of certain antibiotics in livestock for purposes other than disease treatment poses a threat to human health.” (Judge Theodore H. Katz, NRDC, Inc. v. FDA, March 22, 2012) (“Order”). The agency has publicly stated that it considers antibiotic resistance “a mounting public health problem of global significance” as well as “one of the world’s most pressing public health problem.” It planned to address the issue of overuse of antibiotics in farm animals in 1977 when it issued notices of a hearing to drug manufacturers, about 27 years after giving the industry the green light to proceed with the practice. The FDA’s notice announced the agency’s intention to withdraw approval of the use of certain antibiotics, such as penicillin and most tetracyclines, in livestock for the purposes of growth promotion and feed efficiency, which the agency had found had not been proven to be safe.

The FDA, however, never scheduled that hearing and for next 35 years the agency proceeded to do little to regulate the use of penicillin and tetracyclines in livestock. In 2010, it issued an industry friendly draft guidance, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, (still in draft form), which lacked explicit prohibitions on the routine use of antibiotics in healthy farm animals, and was only and merely a “recommendation” and not a a regulation with the force of law. And at the end of 2011, the FDA withdrew its 1977 notice of hearing, stating that the “FDA intends to focus its efforts for now on the potential for voluntary reform and the promotion of the judicious use of antimicrobials in the interest of public health.” And so ended the agency’s half-hearted 34 year attempt to regulate the routine uses of antibiotics in animal feed and water.

It took a lawsuit, filed on May 25, 2011, by the National Resource Defense Counsel, Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen, and Union of Concerned Scientists to get the agency to act. In the lawsuit, plaintiffs were seeking, among other things, a court order compelling the FDA to withdraw approval for the subtherapeutic use of penicillin and tetracyclines in animal feed. On March 22, 2012, a Federal Court in New York issued its decision siding with the plaintiffs.

The court found that the “plain meaning” of the statute requires the Secretary of Health and Human Services “to issue notice and an opportunity for a hearing whenever he finds that a new animal drug is not shown to be safe. If the drug sponsor does not meet his burden of demonstrating that the drug is safe at the hearing, the Secretary must issue an order withdrawing approval of the drug.”

The Court noted that “[r]esearch has shown that the use of antibiotics in livestock leads to the development of antibiotic-resistant bacteria that can be and has been transferred from animals to humans through direct contact, environmental exposure, and the consumption and handling of contaminated meat and poultry products,” and found that:

According to its statutory mandate, the FDA is responsible for continuously monitoring regulated drugs and reviewing new studies of their effectiveness and safety. Given this regulatory structure, it seems clear that Congress intended the FDA to monitor approved animal drugs and issue findings when new evidence indicates that a drug is no longer shown to be safe, triggering the withdrawal process.

The statistics of the human cost of antibiotic resistance are revealing. New York Representative Louise M. Slaughter, who has been attempting to pass legislation, Preservation of Antibiotics for Medical Treatment Act (PAMTA), which would require, among other things, the phasing out the non-therapeutic use in livestock of medically important antibiotics, has stated that:

Antibiotic resistant bacterial infections increase health care costs by over $20 billion each year and increase societal costs by $35 billion. Two million Americans acquire a bacterial infection during their hospital stay every year, and 70 percent of their infections will be resistant to the drugs commonly used to treat them. As a result, every day thirty-eight patients in our hospitals will die of those infections.

In a press release commenting on the Order, Rep. Slaughter stated, “I’m pleased to finally see some progress and I can only hope that we see swift action from the FDA on this looming crisis.”

Data released by FDA of the antibiotics sold in 2009 for both people and food animals showed that almost 80% were reserved for livestock and poultry. It is no longer a secret that the reason behind this massive drugging of animals is the direct result of the commoditization of animals who are confined in large numbers in overcrowded areas, creating hazardous conditions for the animals, workers and the environment. The Pew Commission on Industrial Farm and Animal Production noted, for example, that “[i]t is not uncommon for 25,000 swine, or more, to be raised in one industrial operation, 10,000 dairy cows, and 100,000 broiler chickens or laying hens.” And while we close our eyes and push out the thoughts and images of the horror that often goes on in many of the concentrated animal feeding operations (commonly known as “CAFOs”), the hope is that if the FDA withdrew its approval for antibiotics the meat industry would be forced to rethink its operations and confinement of animals.